NEUROSTIMULATORS AND STIMULATION SYSTEMS

• US 20180178015A1
• Filed: 12/21/2017
• Published: 06/28/2018
• Est. Priority Date: 12/22/2016
• Status: Active Grant

• Current Assignee: Alfred E. Mann Foundation For Scientific Research
• Original Assignee: Alfred E. Mann Foundation For Scientific Research
• Inventors: Dearden, Brian R., Suri, Harshit, Lee, Edward K. F.
• Granted Patent: US 10,639,480 B2
• Time in Patent Office: Days
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36075 Headache or migraine
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters
• CPC Class Codes: A61N 1/36196 Frequency modulation
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

In accordance with the present invention, various embodiments of neurostimulators and stimulation systems are disclosed that provide different shapes and patterns of stimulus pulses and trains of pulses with fixed and no fixed frequencies. The neurostimulator can be configured to provide high frequency stimulation and also be implantable in the head or neck regions in order to stimulate nerves and nerve ganglions in the head and neck regions and also stimulate the brain.

Claims

1. An implantable stimulation system comprising:

a neurostimulator having a housing that is sized and shaped to be implanted in the head or neck; and

at least one stimulation lead that can be connected to the neurostimulator, the lead having one or more electrode contacts,

wherein the neurostimulator is capable of providing a selectable stimulus frequency in at least the range from about 100 Hz to about 4.8 kHz.

2. The system of claim 1, wherein the neurostimulator is capable of providing a selectable stimulus frequency in at least the range from about 500 Hz to about 4.8 kHz.

3. The system of claim 1, wherein the neurostimulator is capable of providing a selectable stimulus frequency in at least the range from about 100 Hz to about 1 kHz.

4. The system of claim 1, wherein the neurostimulator is capable of providing a selectable stimulus frequency in at least the range from about 100 Hz to about 500 Hz.

5. The system of claim 1, wherein the at least one stimulation lead having one or more electrode contacts is configured to stimulate the occipital nerve or its branches.

6. The system of claim 1, wherein the at least one stimulation lead having one or more electrode contacts is configured to stimulate the trigeminal nerve or its branches.

7. The system of claim 1, wherein the at least one stimulation lead is a paddle-type lead, a cuff-type lead, or a linear-type lead, having one or more electrode contacts.

8. The system of claim 1, wherein the housing is not a return or indifferent electrode.

9. The system of claim 1, further comprising:

a patient programmer; and

a clinician programmer.

10. A neurostimulator comprising:

a housing that is sized and shaped to be implanted subcutaneously over the skull; and

at least one lead connector for connecting at least one stimulation lead having one or more electrode contacts,

wherein the neurostimulator is capable of providing stimulation with a pulse electrical stimulus frequency in at least the range from about 100 Hz to about 4.8 kHz.

11. The neurostimulator of claim 10, wherein the neurostimulator is capable of providing a selectable stimulus frequency in at least the range from about 500 Hz to about 4.8 kHz.

12. The neurostimulator of claim 10, wherein the neurostimulator is capable of providing a selectable stimulus frequency in at least the range from about 100 Hz to about 1 kHz.

13. The neurostimulator of claim 10, wherein the neurostimulator is capable of providing a selectable stimulus frequency in at least the range from about 100 Hz to about 500 kHz.

14. A implantable neurostimulator comprising:

an electrical circuit capable of delivering a train of electrical stimuli that has at least a train of n number of pulses in one polarity and followed by a train of m number of pulses in the opposite polarity,

wherein n and m are both 2 or greater whole numbers.

15. The neurostimulator of claim 14, wherein n and m are equal whole numbers and the sum of n pulses is charge-balanced with the sum of m pulses.

16. The neurostimulator of claim 14, wherein n pulses and m pulses have a current amplitude or voltage amplitude which are substantially different.

17. The neurostimulator of claim 14, wherein n and m are unequal whole numbers and the sum of charges provided by n pulses is substantially charge-balanced with the sum of charges provided by m pulses.

18. The neurostimulator of claim 14, wherein the neurostimulator is shaped and sized for implantation in the head or neck subcutaneously.

19. The neurostimulator of claim 14, wherein the neurostimulator is shaped and sized for implantation in the chest region or pectoral region of the body.

20. An implantable neurostimulator comprising:

an electrical circuit capable of delivering, through at least one electrode contact, a train of electrical stimuli that has at least n number of stimuli,

wherein n is 3 or a greater whole number, such that each stimulus is represented by N1, N2, . . . , N-Last in one time window, and

wherein the train of stimuli does not have a fixed frequency.

21. The neurostimulator of claim 20, wherein the frequency is not fixed but is variable as measured between the time duration between N1 and N2 compared to the time duration between N2 and N3.

22. The neurostimulator of claim 20, wherein the duration between adjacent stimuli is entirely randomized with no fixed frequency, wherein the total number of stimuli N1, N2, . . . , N-Last occurring in a time window can be selectable through software programming resident in the neurostimulator.

23. The neurostimulator of claim 20, wherein each stimuli N1, N2, . . . , N-Last is biphasic, having both a peak in both polarity directions and is charge balanced.

24. The neurostimulator of claim 23, wherein each stimuli N1, N2, . . . , N-Last is symmetric and charge balanced.

25. The neurostimulator of claim 23, wherein each stimuli N1, N2, . . . , N-Last is biphasic, not symmetric, and charge balanced.

26. The neurostimulator of claim 20, wherein the neurostimulator is sized and shaped to be implanted in the head or neck subcutaneously.

27. The neurostimulator of claim 20, wherein the housing is comprised of a conductive metal capable of being selected as an indifferent return electrode to operate in a monopolar stimulation mode.

28. A deep brain stimulation system comprising:

an implantable neurostimulator; and

at least one lead that can be connected to the neurostimulator, the lead having one or more electrode contacts and configured to be implanted in the brain,

wherein the neurostimulator is capable of providing a selectable stimulus frequency in at least the range from about 100 Hz to about 4.8 KHz.

29. The system of claim 28, wherein the neurostimulator is capable of providing a selectable stimulus frequency in at least the range from about 500 to about 4.8 kHz.

30. The system of claim 28, wherein the neurostimulator is capable of providing a selectable stimulus frequency in at least the range from about 100 Hz to about 1 kHz.

31. The system of claim 28, wherein the neurostimulator is capable of providing a selectable stimulus frequency in at least the range from about 100 Hz to about 500 Hz.